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BRIEF TITLE: Evaluating the Efficacy and Safety of UGN-101 (Mitomycin Gel) for Instillation on Ablation of Upper Urinary Tract Urothelial Carcinoma in Recurrent Patients From Trial TC-UT-03

A Phase 3b Multicenter Extension Trial Evaluating the Efficacy and Safety of UGN-101 (Mitomycin Gel) for Instillation on Ablation of Upper Urinary Tract Urothelial Carcinoma in Recurrent Patients From Trial TC-UT-03


  • Org Study ID: TC-UT-03/E
  • Secondary ID:
  • NCT ID: NCT04006691
  • NCT Alias:
  • Sponsor: UroGen Pharma Ltd. - Industry
  • Source: UroGen Pharma Ltd.

Brief Summary

This trial is designed to evaluate the efficacy and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).

Detailed Description


This is an open-label, single-arm, Phase 3b multicenter extension trial, designed to evaluate
the efficacy and safety of UGN-101 administered to the UUT in patients who were treated in
Trial TC-UT-03, found to be a CR at the PDE 1 Visit, and are subsequently found to have a
documented recurrence of LG UTUC at FU.

Upon signing of informed consent, the patients will undergo their routine ureteroscopy to
assess durability. A biopsy will be performed at Visit 0, if appropriate, to confirm evidence
of tumor. If a high grade (HG) UTUC is confirmed by biopsy and/or cytology, the patient will
be excluded from the retreatment trial. Eligible patients with confirmed LG non-invasive UTUC
will be treated with 3 to 6 once-weekly instillations of UGN-101 in a retrograde fashion, per
investigator's discretion.

Five weeks (± 1 week) following the last Investigational product (IP) treatment, the patient
will be assessed for efficacy and safety at the PDE 2 Visit. At this visit, the patient will
undergo ureteroscopy and any remaining lesions will be biopsied, and UUT urine wash will be
collected for cytology.

Patients demonstrating CR at the PDE 2 Visit will undergo FU visits at 3, 6, 9, and 12 months
(± 2 weeks) following the PDE 2 Visit.

The trial will be approximately 15 months, per patient: a 3- to 6-week treatment period,
followed by 4 to 6 weeks post-treatment leading up to the PDE 2 Visit, and a 12-month FU post
PDE 2 Visit. This trial will follow the Steering Committee, and a Data Monitoring Committee
(DMC) has been assigned as established for the primary trial TC-UT-03.

Overal Status Start Date Phase Study Type
Recruiting October 1, 2019 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Complete response (CR) rate

Primary Outcome 1 - Time Frame: An average of 11 weeks

Condition:

  • Carcinoma
  • Transitional Cell Carcinoma
  • Transitional Cell Cancer of the Renal Pelvis and Ureter

Eligibility

Criteria:
Main Inclusion Criteria:

1. Patients with recurrent LG UTUC who were found to be CR at the PDE 1 Visit (in Trial
TC-UT-03).

2. Biopsy taken from 1 or more tumors located in the UUT shows LG urothelial carcinoma
(up to 2 months before Visit 0). If there are tumors in both the kidney and the
ureter, at least 1 biopsy should be taken from each location.

3. Urine wash cytology sampled from the UUT documenting the absence of HG urothelial
cancer.

4. Patients must have adequate organ and bone marrow function as determined by routine
laboratory tests.

5. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or
urinalysis

Main Exclusion Criteria:

1. Patient intends to be treated with systemic chemotherapy during the duration of the
trial.

2. Patient with urinary obstruction.

3. Inability to deliver the IP to the UUT.

4. Patient has any other medical or mental condition(s) that make(s) their participation
in the trial unadvisable in the opinion of the treating investigator.

5. Patient has a contraindication to mitomycin treatment, or known sensitivity to
mitomycin.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Ifat Klein, Phd

Role: Study Director

Affiliation: UroGen Pharma

Overall Contact

Name: Madlen Malinowski

Phone: 1-646-768-9533

Email: Madlen.Malinowski@urogen.com

Locations

Facility Status Contact
UCLA - University of California, Los Angeles
Los Angeles, California 90095
United States
Not yet recruiting Chamie Karim, MD
310-206-8183
kchamie@mednet.ucla.edu
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Not yet recruiting Raymond Pak, M.D.
404-683-5298
Pak.Raymond@mayo.edu
John Hopkins University
Baltimore, Maryland 21218
United States
Not yet recruiting Phillip Pierorazio, MD
410-955-6850
philpierorazio@jhmi.edu
Urology Center Las Vegas
Las Vegas, Nevada 89144
United States
Recruiting Michael Verni, M.D.
702-212-3428
mverni@mac.com
Sheba Medical Center
Ramat Gan, 52621
Israel
Not yet recruiting Nir Kleinmann, M.D.
952-53-3398845
nir.kleinmann@gmail.com